DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-13, and 15-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, it is unclear if the “of brain electrical activity data by electroencephalography” is the same data as the “C3/C4 data of an EEG signal of an electroencephalography” previously recited in the claim. It is further unclear if two separate cross-frequency coupling method steps are performed as the claim first recites determining a characteristic value from C3/C4 data using a cross-frequency coupling method in lines 5-8, and then again in the last 5 lines of the claim. For this examination, the claim is being interpreted such that one cross-frequency coupling method is performed on C3/C4 data, the C3/C4 data being the measured and recorded brain electrical activity data.
Further regarding claim 1, the phrase “the predetermined number of said data blocks” lacks proper antecedent basis as there is no previous mention of a predetermined number of data blocks.
Further regarding claim 1, it is unclear if each evaluated data block is assigned to a sleep stage, or if all predetermined data blocks are assigned to a single sleep stage. Clarification is requested. For examination purposes, both interpretations are being applied.
Regarding claim 3, it is unclear what further limitation the claim provides to the method of claim 1 as claim 1 already recites that the brain electrical activity data is performed by means of electroencephalography (and electroencephalography inherently includes measurement sensors).
Regarding claim 4, it is unclear what further limitation the claim provides to the claimed method as claim 1 already recites collecting C3/C4 EEG data. Furthermore, the phrase “the C3/C4 data of an electroencephalography” in claim 4 lacks proper antecedent basis due to the phrase “an electroencephalography” (claim 3 recites an electroencephalography, and therefore it is unclear if the “an electroencephalography” of claim 4 is the same as or different than the recitation in claim 3).
Regarding claim 9, it is unclear what is meant by “subdivided into time intervals being defined”. For examination purposes, the subdivision of the collected data into time-dependent data blocks is being considered the same as subdividing the collected data into “time intervals being defined”.
Regarding claim 10, the phrase “in particular” and the phrase “preferably” render the claim indefinite in that it is unclear as to whether the limitations following each phrase are part of the claimed invention. For examination purposes, each of the limitations following the phrase “in particular” and “preferably” will be considered as optional.
Regarding claim 11, it is unclear what is meant by “the additional data are evaluated as a function of the sleep stages”. Clarification is requested.
Claims not explicitly rejected above are rejected due to their dependence on a rejected base claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-6, 9, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al. (Sleep Stage Classification… – previously cited) in view of Gouveris et al. (Sleep Stage Classification Using Spectral Analyses… – previously cited).
Regarding claims 1, 3, 4, and 15, Sanders et al. discloses a method for classifying a polysomnography (PSG) recording into sleep stages (see TITLE), the method comprising the following steps: classifying the sleep of a human being into a grid with different sleep stages (II. METHODS); providing a characteristic value for a sleep stage (II. METHODS C. Cross-frequency-coupling method); collecting a plurality of information regarding bodily functions over a predetermined period of time in the form of data, wherein collecting the plurality of information comprises at least one measuring of brain electrical activity data by electroencephalography (EEG) and recording the brain electrical activity data with EEG measuring sensors over the predetermined period of time during sleep of the human being (II. METHODS – as EEG data is acquired over an approximately 8hr period [II. METHODS D. Classification], a plurality of information/EEG data points is collected); subdividing the collected data into time-dependent data blocks (II. METHODS - 30 second epoch windows); selecting a predetermined number of data blocks from the data blocks, wherein said data blocks include data on the electrical activity of the brain in the form of EEG signals, and automatically evaluating the brain electrical activity data in each selected data block using a cross-frequency coupling method that determines the characteristic value that allows assignment to a sleep stage defined by the characteristic value (II. METHODS C. Cross-frequency-coupling method); and automatically assigning the evaluated data blocks to a sleep stage based on the characteristic value (II. METHODS C. Cross-frequency-coupling method and D. Classification). Official notice is being taken that it is well known in the art that EEG signals are acquired from brain electrical activity data on the skin of a skull surface of a human being using EEG sensors (see, for example, section [0005] of Huiku’338 – US Pub No. 2005/0182338 – previously cited, and sections [0003-0004] of Lapinlampi et al.’753 – US Pub No. 2008/0009753 – previously cited).
Sanders et al. discloses all of the elements of the current invention, as discussed above, except for the EEG data including C3/C4 EEG data. Gouveris et al. teaches performing sleep stage classification by analyzing EEG signals collected from the C3/C4 EEG electrode positions (Materials and Methods). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have included collecting EEG data from C3/C4 EEG electrode positions in the method of Sanders et al., as Gouveris et al. teaches that signals from those locations can be used to perform sleep stage classification. The modification to Sanders et al. would merely be combining prior art elements according to known methods to yield predictable results. In the combination of Sanders et al. in view of Gouveris et al., the cross-frequency coupling method would be performed on EEG data including C3/C4 data, and the characteristic value would be determined using the cross-frequency coupling method results obtained from the C3/C4 data.
Regarding claim 5, Sanders et al. discloses that the cross-frequency coupling method is applied to theta and gamma waves or to delta and alpha waves of an EEG (II. METHODS C. Cross-frequency-coupling method, and see Figure 3 and description thereof).
Regarding claim 6, Sanders et al. discloses that the cross-frequency coupling method comprises a phase-amplitude coupling (II. METHODS C. Cross-frequency-coupling method).
Regarding claims 9, 16, and 17, Sanders et al. discloses that the collected data are subdivided into time intervals being defined (30 epoch windows).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al. in view of Gouveris et al., as applied to claim 1, further in view of Low et al.’095 (US Pub No. 2007/0016095 – previously cited).
Sanders et al. in view of Gouveris et al. discloses that the selected data blocks (which includes some of the selected data blocks) are transmitted as training data blocks to a linear discriminant analysis (LDA) classifier for creating a classification in the LDA classifier, and that at least a portion of the data blocks not selected as training blocks are transmitted to the LDA classifier and automatically classified into the known sleep stages (II. METHODS D. Classification, and see Figure 4 and description thereof of Sanders et al.).
Sanders et al. in view of Gouveris et al. discloses all of the elements of the current invention, as discussed in paragraph 5 above, except for the classifier being a support vector machine. Low et al.’095 teaches that sleep stage classification based on EEG signals can be performed using either LDA classifiers or support vector machines (section [0164]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Sanders et al. in view of Gouveris et al. by substituting a support vector machine for the LDA classifier as it would merely be the simple substitution of one known classification means for another to obtain predictable results.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al. in view of Gouveris et al. further in view of Low et al.’095, as applied to claim 7, further in view of Banerjee et al.’444 (US Pub No. 2018/0228444 – previously cited).
Sanders et al. in view of Gouveris et al. further in view of Low et al.’095 discloses all of the elements of the current invention, as discussed in paragraph 6 above, except for the support vector machine comprising an algorithm that uses a non-linear basis kernel function. Banerjee et al.’444 teaches that support vector machines comprising an algorithm that uses a non-linear basis kernel function produce optimum classification performance (section [0032]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the support vector machine of Sanders et al. in view of in view of Gouveris et al. further in view of Low et al.’095 such that it comprises an algorithm that uses a non-linear basis kernel function, as Banerjee et al.’444 teaches that this would produce optimum classification performance.
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al. in view of Gouveris et al., as applied to claim 1, further in view of Kayyali et al.’399 (USPN 10,426,399 – previously cited).
Regarding claim 10, Sanders et al. in view of Gouveris et al. discloses all of the elements of the current invention, as discussed in paragraph 5 above, except for measuring and recording additional data on the following bodily functions during the predetermined period of time: cardiac activity, airflow of nasal and/or oral respiration, respiratory excursion of the thorax and abdomen, respiratory sounds, eye movement patterns, and electrical muscle activity in the chin region and on the lower leg, wherein the data is preferably collected by means of the following measuring methods or measuring devices: electrocardiography, microphone, air flow meter, electromyography electrodes.
Kayyali et al.’399 teaches a method for conducting sleep analysis, wherein the sleep analysis not only includes collecting, recording, and analyzing EEG data, but also, at the same time, data pertaining to: cardiac activity, airflow of nasal and/or oral respiration, respiratory excursion of the thorax and abdomen, respiratory sounds, eye movement patterns, and electrical muscle activity in the chin region and on the lower leg, wherein the data is preferably collected by means of the following measuring methods or measuring devices: electrocardiography, microphone, air flow meter, electromyography electrodes (col. 4, line 57 – col. 5, line 34, col. 9, lines 15-44). Kayyali et al.’399 teaches collecting, recording, and analyzing the plurality of different types of bodily function data in order to diagnose sleep disorders and other diseases or conditions with sleep signatures, such as Parkinson’s, epilepsy, chronic heart failure, chronic obstructive pulmonary disorder, or other neurological, cardiac, pulmonary, or muscular disorders (see ABSTRACT, col. 2, lines 47-59). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Sanders et al. in view of Gouveris et al. to include measuring and recording the additional data taught by Kayyali et al.’399 during the predetermined time period, as it would provide a comprehensive sleep study via PSG analysis, and would help diagnose sleep disorders and other diseases or conditions with sleep signatures, such as Parkinson’s, epilepsy, chronic heart failure, chronic obstructive pulmonary disorder, or other neurological, cardiac, pulmonary, or muscular disorders.
Regarding claim 11, as the data of Sanders in view of Gouveris et al. further in view of Kayyali et al.’399 are all recorded throughout a night of sleep, any data evaluated is evaluated as a function of the sleep stages experienced during a night of sleep.
Regarding claims 12 and 13, Kayyali et al.’399 teaches recording the data on bodily functions in a sleep laboratory within a subject’s home (col. 5, lines 26-27). Kayyali et al.’399 teaches that performing the PSG monitoring within a PSG laboratory set up within the subject’s home eliminates a “first night effect”, thus providing more accurate data for sleep diagnosis (col. 5, lines 27-31). Kayyali et al.’399 further teaches that subjects are more comfortable sleeping at home and are more willing to participate in a full PSG study that does not involve traveling or sleeping away from home (col. 5, lines 31-34). With these teachings by Kayyali et al.’399, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have performed the PSG monitoring method of Sanders et al. in view of Gouveris et al. further in view of Kayyali et al.’399 in a sleep laboratory within the human being’s home, as it would (1) provide more accurate data for sleep diagnosis, and (2) make the human being more comfortable and more willing to participate in a full PSG study.
Claims 12 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al. in view of Gouveris et al., as applied to claim 1, further in view of Burns et al.’373 (US Pub No. 2008/0262373 – previously cited).
Regarding claim 12, while Sanders et al. in view of Gouveris et al. discloses that the data on bodily functions is collected in a hospital (II. METHODS of Sanders et al.), it fails to explicitly disclose that the data is collected in a sleep laboratory. Burns et al.’373 teaches of method of automatically diagnosing or assessing rapid eye movement sleep behavior disorder (see ABSTRACT), wherein the method comprises acquiring data on bodily functions in a sleep laboratory for two consecutive nights (sections [0039] and [0068]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Sanders et al. in view of Gouveris et al. so that it collects data on bodily functions of the human being in a sleep laboratory, as taught by Burns et al.’373, as this would allow for the diagnosis and assessment of rapid eye movement sleep behavior disorder.
Regarding claim 18, Burns et al.’373 teaches that the data is collected during a second night (sections [0039] and [0068] – two consecutive nights; and section [0056]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 4, 6-13, and 15-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-6, 7, 9-11, and 13 of U.S. Patent No. 12,558,025. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the US Patent are narrower in scope than the claims of the current invention, encompassing the subject matter recited in the current claims. Any reference meeting the limitations set forth in claims 1, 2, 6, 7, 9-11, 17, and 22 of the copending Application would also meet the requirements set forth in claims 1, 3-13, and 15-18 of the current invention.
Response to Arguments
Applicant's arguments filed 08 December 2025 have been fully considered.
Regarding the rejections of the claims under 35 U.S.C. 112(b), while the amendments have overcome some of the indefiniteness issues within the claims, as seen in paragraph 3 above, indefiniteness issues remain.
Regarding the rejections of claims 1, 3, 5, 6, 9, and 15-17 in view of the previously cited prior art, Applicant’s amendments have warranted a change of rejection under 35 U.S.C. 102 to a rejection under 35 U.S.C. 103. Claim 1 was amended to include the C3/C4 subject matter of previously examined claim 4. As such, Claim 1 is now rejected as being unpatentable over Sanders et al. in view of Gouveris et al., the same art combination used to reject previously examined claim 4. While Applicant has provided arguments against the Sanders et al. reference alone, Applicant has not provided arguments against the combination of Sanders et al. in view of Gouveris et al. Applicant merely asserts that “Gouveris fails to cure such deficiencies” without providing an explanation as to why Gouveris et al. fails to cure the deficiencies of Sanders et al. In response to Applicant’s arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding Applicant’s traversal of the Official notice that was taken, the Examiner notes that Official notice was not taken with regard to the location of the EEG sensors being placed at the C3 and C4 positions. Gouveris et al. was relied upon to modify Sanders et al. such that EEG data from the C3 and C4 positions is obtained, processed, and analyzed for the purpose of sleep stage determination. Official notice was taken with regard to it being well known in the art that EEG signals are acquired from brain electrical activity data on the skin of a skull surface of a human being using EEG sensors. Not only did the Examiner provide two references supporting the Official notice, Applicant also acknowledges on page 8 of the filed Remarks that traditional EEG systems record brain activity on the skin of the scalp.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Wang et al.’090 (US Pub No. 2019/0304090 – previously cited) teaches the advantages of using a non-linear kernel with a radial basis function algorithm in a support vector machine. Javed et al.’257 (US Pub No. 2019/0231257 – previously cited) teaches that conventional PSG monitoring includes recording the data recited in claim 10, and that PSG monitoring comprises two nights of observation in a sleep laboratory. Sotos et al.’981 (US Pub No. 2006/0063981 – previously cited) teaches that PSG monitoring typically includes recording the data recited in claim 10. Bianchi et al.’937 (US Pub No. 2014/0213937 – previously cited) teaches that PSG monitoring typically includes recording the data recited in claim 10. Grossman et al.’073 (US Pub No. 2019/0143073 – previously cited) teaches that PSG monitoring typically includes recording the data recited in claim 10. Slonneger et al.’770 (US Pub No. 2014/0364770 – previously cited) teaches performing PSG monitoring in a home environment. Murphy et al.’064 (US Pub No. 2021/0370064 – previously cited) teaches performing PSG monitoring in a home environment. Li et al. (Deep learning in the cross-time frequency domain… – previously cited) teaches that the gold standard of sleep disorder diagnosis is PSG which includes recording the data recited in claim 10. Chan et al.’086 (US Pub No. 2015/0190086 – previously cited) teaches that conventionally, sleep staging of a human being is done via a PSG study in a sleep laboratory, and that PSG studies include recording the data recited in claim 10.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791